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The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Mozart music
Sponsored by
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults scheduled for total thyroidectomy under general anesthesia

Exclusion Criteria:

  • Visual impairments
  • Hearing impairments
  • Severe anxiety or other psychiatric disorders
  • History of chronic pain
  • Past complications during anesthesia or surgery
  • American Society of Anesthesiologists (ASA) physical status beyond II

Sites / Locations

  • Hygeia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Group

Control Group

Arm Description

Patients received music intervention and usual postoperative care.

Patients received only postoperative usual care.

Outcomes

Primary Outcome Measures

Postoperative Pain
Postoperative Pain was measured with the Visual Analogue Scale (VAS). This is a straight horizontal line of fixed length, usually 100 mm. The ends of the line are defined as the extreme limits of the measured parameter (pain). Specifically, the left end signifies the complete absence of pain and the right end represents the worst possible pain. Patients were asked to rate their pain by indicating a point on the straight line. Higher VAS scores mean more pain intensity. The more is the reduction of VAS score from the baseline measurement, the better is the outcome.

Secondary Outcome Measures

Systolic and diastolic blood pressure
Blood pressure was measured by a patient's monitor.
Heart rate
Heart rate was measured by a patient's monitor.
Respiratory rate
Respiratory rate was measured by a care provider.
Oxygen saturation
Oxygen saturation was measured by a patient's monitor.

Full Information

First Posted
January 5, 2021
Last Updated
January 12, 2021
Sponsor
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04699084
Brief Title
The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
Official Title
The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prolepsis Institute for Preventive, Environmental and Occupational Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.
Detailed Description
Postoperative pain is a major concern in postsurgical patients. Meanwhile, there is a general consensus on minimizing the use of analgesic drugs in patients undergoing total thyroidectomy. Therefore, alternative methods need to be investigated in order to reduce postoperative pain. Although the clinical importance of music has been recognised in other pathological situations, further research is needed to investigate the effect of music on postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were assigned to two groups. One group underwent a music intervention postoperatively, while the other received only usual postoperative care (control group).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Group
Arm Type
Experimental
Arm Description
Patients received music intervention and usual postoperative care.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients received only postoperative usual care.
Intervention Type
Other
Intervention Name(s)
Mozart music
Intervention Description
A 20-minute piece composed by W.A Mozart ( Sonata K. 448 in D Major for 2 pianos) was applied in music group, directly after the arrival of patients in the Post Anesthesia Care Unit (PACU), while they were receiving usual postoperative care.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Postoperative Pain was measured with the Visual Analogue Scale (VAS). This is a straight horizontal line of fixed length, usually 100 mm. The ends of the line are defined as the extreme limits of the measured parameter (pain). Specifically, the left end signifies the complete absence of pain and the right end represents the worst possible pain. Patients were asked to rate their pain by indicating a point on the straight line. Higher VAS scores mean more pain intensity. The more is the reduction of VAS score from the baseline measurement, the better is the outcome.
Time Frame
Change of VAS was evaluated; from the beginning (time of arrival at the PACU, baseline), to the middle (10 minutes after surgery), to the end of the music intervention (20 minutes after surgery) at the PACU and to 2 hours after surgery in the ward.
Secondary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Description
Blood pressure was measured by a patient's monitor.
Time Frame
Change of blood pressure was evaluated during the first postoperative day.
Title
Heart rate
Description
Heart rate was measured by a patient's monitor.
Time Frame
Change of heart rate was evaluated during the first postoperative day.
Title
Respiratory rate
Description
Respiratory rate was measured by a care provider.
Time Frame
Change of respiratory rate was evaluated during the first postoperative day.
Title
Oxygen saturation
Description
Oxygen saturation was measured by a patient's monitor.
Time Frame
Change of oxygen saturation was evaluated during the first postoperative day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults scheduled for total thyroidectomy under general anesthesia Exclusion Criteria: Visual impairments Hearing impairments Severe anxiety or other psychiatric disorders History of chronic pain Past complications during anesthesia or surgery American Society of Anesthesiologists (ASA) physical status beyond II
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Linos, MD, Ph.D.
Organizational Affiliation
Hygeia Hospital, National and Kapodistrian University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hygeia Hospital
City
Athens
ZIP/Postal Code
15123
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy

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